Omontys

"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...

Omontys

PATIENT INFORMATION

if you are told by your healthcare provider that there is
new information about OMONTYS.

if you are told by your healthcare provider that you may
inject OMONTYS at home, read this Medication Guide each time you receive a new
supply of medicine.

This Medication Guide does not take the place of talking
to your healthcare provider about your medical condition or your treatment.
Talk with your healthcare provider regularly about the use of OMONTYS and ask
if there is new information about OMONTYS.

What is the most important information I should know
about OMONTYS?

Using OMONTYS or other erythropoiesis-stimulating agents
(ESAs) can lead to serious side effects including death.

If you decide to take OMONTYS, your healthcare provider
should prescribe the smallest dose of OMONTYS that is needed to reduce your
chance of needing red blood cell transfusions.

You may get serious heart problems such as heart attack,
stroke, heart failure, and may die sooner if you are treated with OMONTYS to
reach a normal or near-normal hemoglobin level.

You may get blood clots while receiving OMONTYS. If you
are receiving OMONTYS and you are going to have surgery, talk to your
healthcare provider about whether or not you need to take a blood thinner to
lessen the chance of blood clots during or following surgery. Clots can form in
blood vessels (veins), especially in your leg (deep venous thrombosis or DVT).
Pieces of a blood clot may travel to the lungs and block the blood circulation
in the lungs (pulmonary embolus).

Call your healthcare provider or get medical help right
away if you have any of these symptoms of blood clots:

Chest pain

Trouble breathing or shortness of breath

Pain in the legs, with or without swelling

A cool or pale arm or leg

Sudden confusion, trouble speaking, or understanding
others' speech

Sudden numbness or weakness of the face, arm, or leg,
especially on one side of your body

OMONTYS is a prescription medicine that works like the
human protein erythropoietin. OMONTYS is given to treat anemia (low red blood
cells) in adults with chronic kidney disease (CKD) who are on dialysis.

OMONTYS stimulates your bone marrow to make more red
blood cells. Having more red blood cells raises your hemoglobin level. If your
hemoglobin level stays too high or if your hemoglobin goes up too quickly, this
may lead to serious health problems which may result in death. These serious
health problems may happen even if you take OMONTYS and do not have an increase
in your hemoglobin level.

OMONTYS should not be used for the treatment of anemia:

if you have chronic kidney disease (CKD) and are not on
dialysis,

if you are receiving treatment for cancer and your anemia
is not caused by CKD,

in place of emergency treatment for anemia (red blood
cell transfusions).

OMONTYS has not been proven to improve the quality of
life, fatigue, or well-being.

Your healthcare provider should do blood tests to check
your hemoglobin and iron levels before and during your treatment with OMONTYS.

OMONTYS is given one time a month into the vein, through
your hemodialysis vascular access (intravenous), or under your skin
(subcutaneous).

OMONTYS should be given by your healthcare provider. In
some cases, your healthcare provider may allow you or your caregiver to give
the injections at home.

If you or your caregiver has been trained to give the
injections at home, it is important that you:

Carefully follow the instructions that your healthcare
provider gives you. Be sure that you read, understand, and follow the
“Instructions for Use” that come with OMONTYS.

Use OMONTYS exactly as your healthcare provider tells you
to. Do not change the dose of OMONTYS unless told to do so by your healthcare
provider.

Your healthcare provider will show you or your caregiver
how much OMONTYS to use, how to inject it, how often it should be injected and
how to safely dispose of the used containers, needles and syringes.

If you miss a dose of OMONTYS, call your healthcare
provider right away for instructions on what to do.

If you inject more than the prescribed amount of OMONTYS,
call your healthcare provider right away for instructions on what to do.

What are the possible side effects of OMONTYS?

OMONTYS may cause serious side effects, including:

See “What is the most important information I should
know about OMONTYS?”

High blood pressure. High blood pressure is a
common side effect of OMONTYS in people with chronic kidney disease. Your blood
pressure may go up or be difficult to control with blood pressure medicine
while taking OMONTYS. This can happen even if you have never had high blood
pressure before. Your healthcare provider should check your blood pressure
often. If your blood pressure does increase, your healthcare provider may
prescribe new or more blood pressure medicine.

Serious allergic reactions. Serious allergic
reactions can cause dizziness or fainting because of a drop in blood pressure,
trouble breathing, tightness in the chest, swelling around your mouth, tongue
or face, or itching all over your body. If you have a serious allergic
reaction, stop using OMONTYS and call your healthcare provider or get emergency
medical help right away.

Antibodies to OMONTYS. Your body may make
antibodies to OMONTYS. These antibodies can block or lessen your body's ability
to make red blood cells and cause you to have severe anemia. Call your
healthcare provider if you have unusual tiredness, lack of energy, dizziness,
or fainting. You may need to stop taking OMONTYS.

Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.

These are not all the possible side effects of OMONTYS.
For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store OMONTYS?

Keep OMONTYS in the original package.

Protect OMONTYS from light.

Store OMONTYS in the refrigerator between 36 °F to 46 °F
(2 °C to 8 °C).

If a refrigerator is not available, OMONTYS vials and
pre-filled syringes can be stored at 77 °F or less (25 °C or less) for up to 30
days.

Throw away multiple use vials of OMONTYS no later than 28
days from the first day that you put a needle into the vial.

OMONTYS single use vials and pre-filled syringes should
be used only one time. Dispose of the single use vial and the pre-filled
syringe after use even if there is medicine left in the container.

Keep OMONTYS and all medicines out of the reach of
children.

General Information about the safe and effective use
of OMONTYS

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use OMONTYS for a condition for
which it was not prescribed. Do not give OMONTYS to other people, even if they
have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important
information about OMONTYS. If you would like more information about OMONTYS,
talk with your healthcare provider. You can ask your healthcare provider or
pharmacist for information about OMONTYS that is written for healthcare
professionals.

For more information go to www.omontys.com or call
1-855-466-6689.

What are the ingredients in OMONTYS?

Active ingredient: peginesatide

Inactive ingredients:

Single Use Vials and Single Use Pre-filled Syringes:
sorbitol, sodium phosphate monobasic (dihydrate), sodium phosphate dibasic,
polysorbate 20, and sodium hydroxide in Water for Injection.

Multiple Use Vials: sorbitol, phenol, L-methionine,
glacial acetic acid, and sodium hydroxide in Water for Injection.

This Medication Guide has been approved by the U.S. Food
and Drug Administration.

Last reviewed on RxList: 12/19/2012
This monograph has been modified to include the generic and brand name in many instances.